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HHS to propose revisions to regulations on conducting research on human subjects

The U.S. Department of Health and Human Services (HHS) has published an advance notice of proposed rulemaking (ANPR) announcing its intention to revise regulations for research involving human subjects. 76 Fed. Reg. 44,512 (7/26/11). The ANPR seeks public comments on “how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.”

If enacted, the proposed revisions would modify existing federal regulations for protecting human subjects known as the “Common Rule,” codified at 45 C.F.R. part 46, which has been in place since 1991. The rule, a baseline standard of ethics, has been adopted by 15 federal agencies, including EPA; it requires that federally funded “investigators in most instances obtain and document the informed consent of research subjects, and describes requirements for institutional review board (IRB) membership.” The rule also delineates “criteria for, and levels of, IRB review” of human subjects research projects.

The proposed revisions would extend federal oversight to all research conducted at U.S. institutions receiving funding from agencies that have adopted the Common Rule. They would also give subjects the opportunity to decide whether their biological material, such as blood or tissue, could be used for further research. The proposal would also refine the risk-based framework for research review conducted by IRBs to enable them to concentrate their resources on research that poses higher risks to subjects and would make several other procedural revisions. The agency requests comments on the ANPR by September 26, 2011.